EFED: Environmental Factors and Embryonic Development Project

Sponsor

Nanjing Jinling Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04182503

Collaborator

Peking University (Other), Sun Yat-sen University (Other), Shandong University (Other), Zunyi Medical College (Other), Zhejiang University (Other), Huazhong University of Science and Technology (Other)

100,000

Enrollment

Locations

40.6

Anticipated Duration (Months)

5263.2

Patients Per Site

129.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The Environmental Factors and Embryonic Development Project was set up to investigate environmental exposures and behavioral factors responsible for embryonic dysplasia and gestational complications in pregnant women.

Condition or Disease	Intervention/Treatment	Phase
Spontaneous Abortion Fetal Death Stillbirth Birth Defects Preterm Birth Low Birth Weight Pregnancy With Medical Condition (Non-Specific) Gestational Diabetes Gestational Hypertension	Other: No intervention

Detailed Description

The Environmental Factors and Embryonic Development Project is about to recruit pregnant women from 16 cities, including Beijing, Guangzhou, Jinan, Nanjing, Hangzhou, Wuhan, Zunyi, Xiangyang, Nantong, Suizhou, Huangshi, Changzhou, Suqian, Shiyan, Xiaogan, and Huanggang. The project plans to recruit 6000-12000 participants in each city. Biological samples, questionnaires and data for embryonic dysplasia and gestational complications of pregnant women will be collected. The study includes four stages. In the first stage, the investigators will identify external environmental factors and behavioral factors that are associated with embryonic dysplasia and gestational complications in pregnant women based on external exposure monitoring strategies. In the second and third stages, the investigators will conduct several nested case-control studies based on our prospective cohort. Internal exposure monitoring will be applied to identify environmental endocrine disruptors which are associated with embryonic dysplasia and gestational complications in pregnant women in the second stage. In the third stage, the investigators will conduct genome-wide association study (GWAS) to screen susceptible genes or polymorphisms that are associated with embryonic dysplasia and gestational complications in pregnant women, identify any gene-environmental interactions with reference to the findings of the 1st and 2nd stages, and finally establish a comprehensive disease risk prediction model. In the fourth stage, the investigators will build animal models in order to identify the mechanisms how high-risk environmental exposures or behavioral factors as identified in the above stages may lead to embryonic dysplasia and gestational complications in pregnant women. The research team of the 16 cities are from Peking University (Beijing), Sun Yat-sen University (Guangzhou), Shandong University (Jinan), Chinese People's Liberation Army Eastern Theater General Hospital (Nanjing, Nantong, Changzhou, and Suqian), Zhejiang University (Hangzhou), Huazhong University of Science and Technology (Wuhan, Xiangyang, Suizhou, Huangshi, Shiyan, Xiaogan, and Huanggang), Zunyi Medical University (Zunyi), respectively. The core members of each research team are composed of experts from different disciplines in the field of public health.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Investigation on the Health Effects of Environmental and Behavioral Factors on Embryonic Development and Pregnancy Based on Internal and External Exposure Monitoring

Actual Study Start Date :

Aug 12, 2019

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Beijing	Other: No intervention This is a multi-city observational cohort study without intervention.
Guangzhou	Other: No intervention This is a multi-city observational cohort study without intervention.
Jinan	Other: No intervention This is a multi-city observational cohort study without intervention.
Nanjing	Other: No intervention This is a multi-city observational cohort study without intervention.
Hangzhou	Other: No intervention This is a multi-city observational cohort study without intervention.
Wuhan	Other: No intervention This is a multi-city observational cohort study without intervention.
Zunyi	Other: No intervention This is a multi-city observational cohort study without intervention.
Xiangyang	Other: No intervention This is a multi-city observational cohort study without intervention.
Nantong	Other: No intervention This is a multi-city observational cohort study without intervention.
Suizhou	Other: No intervention This is a multi-city observational cohort study without intervention.
Huangshi	Other: No intervention This is a multi-city observational cohort study without intervention.
Changzhou	Other: No intervention This is a multi-city observational cohort study without intervention.
Suqian	Other: No intervention This is a multi-city observational cohort study without intervention.
Shiyan	Other: No intervention This is a multi-city observational cohort study without intervention.
Xiaogan	Other: No intervention This is a multi-city observational cohort study without intervention.
Huanggang	Other: No intervention This is a multi-city observational cohort study without intervention.

Outcome Measures

Primary Outcome Measures

Incidence of spontaneous abortion [up to 28 gestational weeks]
Incidence of fetal death/stillbirth [after 20 gestational weeks to delivery]
Incidence of birth defects [Delivery]
Incidence of low birth weight [Delivery]
Incidence of preterm birth [Delivery]
Incidence of pregnancy with heart disease [During pregnancy (up to 10 months)]
Incidence of pregnancy with hyperthyroidism [During pregnancy (up to 10 months)]
Incidence of gestational diabetes [During pregnancy (up to 10 months)]
Incidence of gestational hypertension [During pregnancy (up to 10 months)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

pregnancy within 13 weeks;
age between 20-45 years;
natural conception;
singleton pregnancy;
living in the local area for one year or more.

Exclusion Criteria:

pregnant women with serious chronic diseases and infectious diseases (such as cancer, chronic cardiovascular and cerebrovascular diseases, chronic renal failure, HIV infection);
have participated in other scientific research projects;
refuse to participate or are unwilling to sign informed consent.;
are unable to guarantee delivery in our designated hospitals.

Contacts and Locations

Locations

	Site	City	State	Country
1	Haidian Maternal and Child Healthcare Hospital	Beijing	Beijing	China
2	Guangdong General Hospital	Guangzhou	Guangdong	China
3	Meitan People's Hospital	Zunyi	Guizhou	China
4	Renhuai Hospital of Traditional Chinese Medicine	Zunyi	Guizhou	China
5	The First Affiliated Hospital of Zunyi Medical University	Zunyi	Guizhou	China
6	The Second Affliated Hospital of Zunyi Medical University	Zunyi	Guizhou	China
7	People's Hospital of Qichun County	Huanggang	Hubei	China
8	Huangshi Maternal and Child Healthcare Hospital	Huangshi	Hubei	China
9	Shiyan Maternal and Child Healthcare Hospital	Shiyan	Hubei	China
10	Maternal and Child Healthcare and Family Planning Service Center of Zengdu District	Suizhou	Hubei	China
11	Huangpi Maternal and Child Healthcare Hospital	Wuhan	Hubei	China
12	Maternal and Child Healthcare Hospital of HuBei	Wuhan	Hubei	China
13	Xiangyang No. 1 People's Hospital, Hubei University of Medicine	Xiangyang	Hubei	China
14	Anlu Maternal and Child healthcare Hospital	Xiaogan	Hubei	China
15	Changzhou Second People's Hospital	Changzhou	Jiangsu	China
16	Nantong Maternal and Child Healthcare Hospital	Nantong	Jiangsu	China
17	Shuyang Hospital Affiliated to Xuzhou Medical University	Suqian	Jiangsu	China
18	Center for Reproductive Medicine, Shandong University	Jinan	Shandong	China
19	Women's Hospital, School of Medicine, Zhejiang University	Hanzhou	Zhejiang	China